Medical Affairs Director Brazil & Head of Medical Affairs LATAM

Title:

Medical Affairs Director Brazil & Head of Medical Affairs LATAM

Company:

Beaufour Ipsen Farmaceutica Ltda

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Medical Affairs Director Brazil & Head of Medical Affairs LATAM

This Opportunity will be based in São Paulo, Brazil/ hybrid working model

ROLE SUMMARY

The Country Medical Director is responsible for defining and leading the execution of the overall strategy for the medical function, including pharmacovigilance, medical information, customer service, local clinical operations, and medical excellence within the global medical framework. This strategy is adapted, when necessary, to local requirements through strong medical expertise, while ensuring full compliance with all laws and codes and adhering to high ethical and quality standards. The goal is to generate added value for all patients and customers, thereby contributing to the company’s business success.

The Country Medical Director plays a key leadership role, sharing responsibility for the development and execution of the country’s strategic and operational plans as a member of the national leadership team and as the leader of the medical function.

As Head of LATAM, this role is responsible for aligning the region’s strategy with global strategies, representing the region in IMALT, participating in the regional leadership team, and supporting the integration of joint initiatives across countries in the region.

MAIN RESPONSIBILITIES

Define and implement the local Medical Affairs strategy

• Lead the development and implementation of strategic and operational plans in the country, aligned with Ipsen Group’s mission, strategy, and values, in order to achieve global and local objectives
• Ensure the successful execution of the medical strategy in collaboration with responsible cross-functional teams
• Overall responsibility for resource allocation and budget control within the medical department, including corrective actions as needed
• Conduct proper medical due diligence, ensuring that Ipsen products maintain a positive benefit-risk profile, with an unwavering commitment to patient safety
• Ensure appropriate lifecycle management for all new and existing products
• Represent the country internally within the global medical organization

Manage day-to-day Medical Affairs activities:

• Coordinate and oversee the medical strategy, aligned with product strategies, in partnership with cross-functional teams
• When appropriate, provide promotional scientific information, clinical study insights, and training for sales representatives, ensuring compliance with internal SOPs, GCP, and applicable regulations
• Implement and manage patient support and diagnostic support programs in line with internal and external guidelines
• Ensure that all reasonable and necessary medical activities are planned and executed to generate value for patients and customers, while supporting and building commercial success within the relevant indications
• Maintain up-to-date clinical knowledge and expertise
• Medical activities include, but are not limited to, medical information, medical education, data generation, publications, medical representation, patient safety, and KOL management

  Responsible for Pharmacovigilance

• Act as the Qualified Person responsible for pharmacovigilance before local regulatory authorities
• Manage drug safety activities within the country
• Ensure that all products are overseen by qualified specialists and that cross-functional teams receive appropriate medical information
• Ensure compliance with local pharmacovigilance regulations and alignment with global procedures

Lead the Medical Excellence function

• Manage activities related to best execution practices and ensure alignment of local SOPs with local regulations and Ipsen internal policies
• Manage Medical Information and Customer Service (SAC) activities, ensuring proper oversight of service providers and compliance with local regulations and internal standards
• Coordinate the effective execution of field medical teams in alignment with their managers, including appropriate training

Oversee local clinical operations and execution:

• Identify and implement post-approval and unregistered Sponsored Clinical Studies, as well as Investigator-Initiated Studies, aligned with global medical strategy and asset data generation plans
• Ensure timely, compliant, and high-quality execution of all types of studies (including Ipsen-sponsored, national, international, interventional, non-interventional, prospective, retrospective, PASS, PAES, ISS), within agreed and available budgets, in consultation with the relevant teams and in line with the prescribed corporate strategy
• Develop strategies, where appropriate, to leverage Real-World Data (RWD) and generate relevant Real-World Evidence (RWE) to support local and global objectives, including but not limited to potential label extensions and market access
• Take appropriate action in case of deviations

Represent Ipsen with external partners and authorities:

• Represent the country medical team and Ipsen’s medical position to external opinion leaders, medical organizations, patient organizations, and regulatory authorities
• Collaborate with colleagues from other departments to build proactive and effective cross-functional communication, as well as to foster potential external partnerships
• Serve as the medical-scientific point of contact for Key Thought Leaders (KTLs)
• Represent Ipsen locally with partner companies

Oversee regional medical activities

• Represent LATAM in IMALT and within the global medical organization
• Represent the medical function in the regional leadership team
• Coordinate integrated actions across countries in the region
• Support the development of regional talent and promote potential exchanges across LATAM countries
• Identify opportunities to optimize resources and foster development across LATAM countries
• Oversee and support the implementation of “medical transformation” and “medical evolution” initiatives across the region.

EXPERIENCE, KNOWLEDGE, CAPABILITIES

Education / Certifications:

• Degree in Medicine or another higher qualification in Health Sciences
• A Master’s degree in Pharmaceutical Industry / Clinical Trials would be an advantage

Experience:

• Minimum of 8 years of experience in the Pharmaceutical Industry or biotechnology companies in High Specialty Therapy Areas
• Must have significant experience in Medical Affairs, including the design and oversight of Phase IV clinical studies
• At least 5 years of management or leadership experience
• Comprehensive understanding of the Pharmaceutical Industry and clinical operations

Languages:

• Fluency in Portuguese and English

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.